Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-01-05 @ 12:00 AM
Study NCT ID:
NCT06122259
Status:
RECRUITING
Last Update Posted:
2023-11-08
First Post:
2023-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Febrile Illness in Guinea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'A venous blood volume of up to 10.5 ml will be collected from all participants to meet needs for routine clinical laboratory analysis and monitoring as well as study related laboratory analysis and sample storage needs at inclusion.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}, 'targetDuration': '21 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-07', 'studyFirstSubmitDate': '2023-11-01', 'studyFirstSubmitQcDate': '2023-11-07', 'lastUpdatePostDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pattern of symptoms and laboratory results at presentation and during follow-up', 'timeFrame': 'Day 0 and day 21', 'description': 'Proportion will be estimated'}, {'measure': 'Syndromic and/or etiologic diagnoses as established at day 21', 'timeFrame': 'Day 0', 'description': 'Proportion will be estimated'}, {'measure': 'Pattern and duration of antibiotic use (and other treatments)', 'timeFrame': 'Day 0', 'description': 'Proportion and mean or median will be estimated'}, {'measure': 'Immediate or secondary hospital admissions and of secondary/unscheduled visits', 'timeFrame': 'Day 0 and day 21', 'description': 'Proportion will be estimated'}, {'measure': 'Participants alive (with or without symptoms) or dead at day 21.', 'timeFrame': 'Day 21', 'description': 'Survival or mortality rate will be estimated'}], 'secondaryOutcomes': [{'measure': 'White blood cells and C-reactive protein levels at baseline and association with syndromic/etiologic diagnoses and with patient outcome at day 21', 'timeFrame': 'Day 0', 'description': 'Mean or median level will be estimated'}, {'measure': 'Association of seasonal, geographical, demographic, clinical and first-line laboratory variables (malaria RDT and smear, biochemistry) with presenting syndromes/main etiologies', 'timeFrame': 'Day 0', 'description': 'OR or RR will be estimated as appropriate'}, {'measure': 'Confirmed arboviral pathogens and identification of epidemiological/clinical/laboratory predictors', 'timeFrame': 'Day 0', 'description': 'Proportions will be estimated'}, {'measure': 'Cases fulfilling any of the case definitions of the 20 epidemic-prone infections under surveillance as compared to the final diagnosis and proportion of them timely reported to health authorities', 'timeFrame': 'Day 0', 'description': 'Proportions will be estimated'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Febrile Illness']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'World health organization. The WHO AWaRe (Access, Watch, Reserve) antibiotic book. WHO. 2022. https://www.who.int/publications/i/item/9789240062382. Accessed 11 Dec 2022'}, {'pmid': '26633014', 'type': 'RESULT', 'citation': 'Crump JA, Kirk MD. Estimating the Burden of Febrile Illnesses. PLoS Negl Trop Dis. 2015 Dec 3;9(12):e0004040. doi: 10.1371/journal.pntd.0004040. eCollection 2015 Dec. No abstract available.'}, {'pmid': '31344116', 'type': 'RESULT', 'citation': 'Roddy P, Dalrymple U, Jensen TO, Dittrich S, Rao VB, Pfeffer DA, Twohig KA, Roberts T, Bernal O, Guillen E. Quantifying the incidence of severe-febrile-illness hospital admissions in sub-Saharan Africa. PLoS One. 2019 Jul 25;14(7):e0220371. doi: 10.1371/journal.pone.0220371. eCollection 2019.'}, {'pmid': '30226134', 'type': 'RESULT', 'citation': 'Carugati M, Zhang HL, Kilonzo KG, Maze MJ, Maro VP, Rubach MP, Crump JA. Predicting Mortality for Adolescent and Adult Patients with Fever in Resource-Limited Settings. Am J Trop Med Hyg. 2018 Nov;99(5):1246-1254. doi: 10.4269/ajtmh.17-0682.'}, {'pmid': '30478314', 'type': 'RESULT', 'citation': 'Alegana VA, Maina J, Ouma PO, Macharia PM, Wright J, Atkinson PM, Okiro EA, Snow RW, Tatem AJ. National and sub-national variation in patterns of febrile case management in sub-Saharan Africa. Nat Commun. 2018 Nov 26;9(1):4994. doi: 10.1038/s41467-018-07536-9.'}, {'pmid': '29454844', 'type': 'RESULT', 'citation': 'Maze MJ, Bassat Q, Feasey NA, Mandomando I, Musicha P, Crump JA. The epidemiology of febrile illness in sub-Saharan Africa: implications for diagnosis and management. Clin Microbiol Infect. 2018 Aug;24(8):808-814. doi: 10.1016/j.cmi.2018.02.011. Epub 2018 Feb 15.'}, {'pmid': '26126200', 'type': 'RESULT', 'citation': 'Prasad N, Murdoch DR, Reyburn H, Crump JA. Etiology of Severe Febrile Illness in Low- and Middle-Income Countries: A Systematic Review. PLoS One. 2015 Jun 30;10(6):e0127962. doi: 10.1371/journal.pone.0127962. eCollection 2015.'}, {'pmid': '33891560', 'type': 'RESULT', 'citation': "Steketee RW, Choi M, Linn A, Florey L, Murphy M, Panjabi R. World Malaria Day 2021: Commemorating 15 Years of Contribution by the United States President's Malaria Initiative. Am J Trop Med Hyg. 2021 Apr 23;104(6):1955-1959. doi: 10.4269/ajtmh.21-0432."}, {'pmid': '27059657', 'type': 'RESULT', 'citation': 'Iroh Tam PY, Obaro SK, Storch G. Challenges in the Etiology and Diagnosis of Acute Febrile Illness in Children in Low- and Middle-Income Countries. J Pediatric Infect Dis Soc. 2016 Jun;5(2):190-205. doi: 10.1093/jpids/piw016. Epub 2016 Apr 7.'}, {'pmid': '32896654', 'type': 'RESULT', 'citation': "Boillat-Blanco N, Mbarack Z, Samaka J, Mlaganile T, Kazimoto T, Mamin A, Genton B, Kaiser L, D'Acremont V. Causes of fever in Tanzanian adults attending outpatient clinics: a prospective cohort study. Clin Microbiol Infect. 2021 Jun;27(6):913.e1-913.e7. doi: 10.1016/j.cmi.2020.08.031. Epub 2020 Sep 4."}, {'pmid': '24571753', 'type': 'RESULT', 'citation': "D'Acremont V, Kilowoko M, Kyungu E, Philipina S, Sangu W, Kahama-Maro J, Lengeler C, Cherpillod P, Kaiser L, Genton B. Beyond malaria--causes of fever in outpatient Tanzanian children. N Engl J Med. 2014 Feb 27;370(9):809-17. doi: 10.1056/NEJMoa1214482."}, {'pmid': '34173960', 'type': 'RESULT', 'citation': 'Wang H, Zhao J, Xie N, Wang W, Qi R, Hao X, Liu Y, Sevalie S, Niu G, Zhang Y, Wu G, Lv X, Chen Y, Ye Y, Bi S, Moseray M, Cellessy S, Kalon K, Baika DI, Luo Q. A Prospective Study of Etiological Agents Among Febrile Patients in Sierra Leone. Infect Dis Ther. 2021 Sep;10(3):1645-1664. doi: 10.1007/s40121-021-00474-y. Epub 2021 Jun 26.'}, {'pmid': '29733254', 'type': 'RESULT', 'citation': 'Muianga A, Pinto G, Massangaie M, Ali S, Oludele J, Tivane A, Falk KI, Lagerqvist N, Gudo ES. Antibodies Against Chikungunya in Northern Mozambique During Dengue Outbreak, 2014. Vector Borne Zoonotic Dis. 2018 Aug;18(8):445-449. doi: 10.1089/vbz.2017.2261. Epub 2018 May 7.'}, {'pmid': '33731022', 'type': 'RESULT', 'citation': 'Ushijima Y, Abe H, Nguema Ondo G, Bikangui R, Massinga Loembe M, Zadeh VR, Essimengane JGE, Mbouna AVN, Bache EB, Agnandji ST, Lell B, Yasuda J. Surveillance of the major pathogenic arboviruses of public health concern in Gabon, Central Africa: increased risk of West Nile virus and dengue virus infections. BMC Infect Dis. 2021 Mar 17;21(1):265. doi: 10.1186/s12879-021-05960-9.'}, {'type': 'RESULT', 'citation': 'World Health Organization. Integrated Management of Childhood Illness (IMCI)_chart booklet. Geneva; 2014. Link: https://www.who.int/publications/m/item/integrated-management-of-childhood-illness---chart-booklet-(march-2014)'}, {'pmid': '26161535', 'type': 'RESULT', 'citation': "Shao AF, Rambaud-Althaus C, Samaka J, Faustine AF, Perri-Moore S, Swai N, Kahama-Maro J, Mitchell M, Genton B, D'Acremont V. New Algorithm for Managing Childhood Illness Using Mobile Technology (ALMANACH): A Controlled Non-Inferiority Study on Clinical Outcome and Antibiotic Use in Tanzania. PLoS One. 2015 Jul 10;10(7):e0132316. doi: 10.1371/journal.pone.0132316. eCollection 2015."}, {'pmid': '30011274', 'type': 'RESULT', 'citation': 'Guillebaud J, Bernardson B, Randriambolamanantsoa TH, Randrianasolo L, Randriamampionona JL, Marino CA, Rasolofo V, Randrianarivelojosia M, Vigan-Womas I, Stivaktas V, Venter M, Piola P, Heraud JM. Study on causes of fever in primary healthcare center uncovers pathogens of public health concern in Madagascar. PLoS Negl Trop Dis. 2018 Jul 16;12(7):e0006642. doi: 10.1371/journal.pntd.0006642. eCollection 2018 Jul.'}, {'pmid': '32818139', 'type': 'RESULT', 'citation': 'van Griensven J, Cnops L, De Weggheleire A, Declercq S, Bottieau E. Point-of-Care Biomarkers to Guide Antibiotic Prescription for Acute Febrile Illness in Sub-Saharan Africa: Promises and Caveats. Open Forum Infect Dis. 2020 Jun 30;7(8):ofaa260. doi: 10.1093/ofid/ofaa260. eCollection 2020 Aug.'}, {'pmid': '29684634', 'type': 'RESULT', 'citation': "Keitel K, D'Acremont V. Electronic clinical decision algorithms for the integrated primary care management of febrile children in low-resource settings: review of existing tools. Clin Microbiol Infect. 2018 Aug;24(8):845-855. doi: 10.1016/j.cmi.2018.04.014. Epub 2018 Apr 21."}]}, 'descriptionModule': {'briefSummary': 'To date, the underlying causes of community-acquired fever, particularly non-malarial fever, are insufficiently documented in Guinea. Moreover, diagnostic capacity is limited, leading to inadequate prescription of antibiotics and antimalarials, as well as substantial delay in outbreak recognition. Thus, the investigators undertook a prospective observational multi-centric cohort study of febrile patients presenting at the emergency and outpatient department of selected health centers, districts and regional hospitals in four ecologically distinct sentinel health districts in Guinea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Febrile patients presenting with documented fever (\\> 37.5°C, axillary temperature) or reporting fever within the prior 24 hours (≤37.5°C, axillary temperature) at the emergency or outpatient department of the selected health facilities.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥2 months old\n* Documented fever (axillary temperature \\>37.5°C) at presentation or fever reported within the prior 24 hours\n* Availability for follow-up for 21 days\n* Willingness and ability of the patient or culturally acceptable representative to give informed consent for participation in the study\n\nExclusion Criteria:\n\n* History of hospitalization (for \\> 48 hours within the last 14 days) at any health facility'}, 'identificationModule': {'nctId': 'NCT06122259', 'acronym': 'MuSIFe', 'briefTitle': 'Febrile Illness in Guinea', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Centre National de Formation et de Recherche en Sante Rurale'}, 'officialTitle': 'Multidisciplinary Surveillance and Investigation of Febrile Illness in Guinea', 'orgStudyIdInfo': {'id': 'IRB/RR/AC/041_1616/22_ITM'}, 'secondaryIdInfos': [{'id': '139/CNERS/23', 'type': 'OTHER', 'domain': "Comité National d'Ethique pour la Recherche en Santé, Guinea"}, {'id': 'IRB/RR/AC/041_1616/22', 'type': 'OTHER', 'domain': 'Institutional Review Board of the Institute of Tropical Medicine, Antwerp, Belgium'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2649', 'city': 'Maférinya', 'state': 'Forécariah', 'status': 'RECRUITING', 'country': 'Guinea', 'contacts': [{'name': 'Alsény Yarie Camara, MD, MPH', 'role': 'CONTACT', 'email': 'aycamara@maferinyah.org'}, {'name': 'Armand Saloun Kamano, MD', 'role': 'CONTACT', 'email': 'askamano@maferinyah.org'}, {'name': 'Karifa Kourouma, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Alexandre Delamou, MD, MPH, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Abdoul Habib Beavogui, MD, MSc, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Emmanuel Bottieau, MD, MSc, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Isabel Brosius, MD, MSC', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Steven Declercq, MD, MPH', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Koen Vercauteren, PharmaD, MSc, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Eugene Bangwen, MPH', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Laurens Liesenborghs, MD, MSc, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre National de Formation et de Recherche en Santé Rurale', 'geoPoint': {'lat': 9.545, 'lon': -13.28028}}], 'centralContacts': [{'name': 'Karifa Kourouma, MD, MSc', 'role': 'CONTACT', 'email': 'KKourouma@maferinyah.org', 'phone': '+224-628-765-320'}, {'name': 'Alexandre Delamou, MD, MPH, PhD', 'role': 'CONTACT', 'email': 'adelamou@maferinyah.org', 'phone': '+224-628-594-765'}], 'overallOfficials': [{'name': 'Emmanuel Bottieau, MD, MSc, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institute of Tropical Medicine, Antwerp, Belgium'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Yet to be finalized.', 'ipdSharing': 'YES', 'description': 'This is under development and will be filled when finalized.', 'accessCriteria': 'Yet to be finalized. However, investigators are opened to collaborate on that data that will be generated.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre National de Formation et de Recherche en Sante Rurale', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Institute of Tropical Medicine, Belgium', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Karifa Kourouma', 'investigatorAffiliation': 'Centre National de Formation et de Recherche en Sante Rurale'}}}}